First annual report of the EU Member State Coordination Group on HTA (HTACG)

On February 16, 2026, the Member State Coordination Group on HTA (HTACG) released its first annual report, detailing all activities of the group and its subgroups in 2025 within the joint EU-level HTA framework. The framework became fully operational on January 12, 2025, when Regulation (EU) 2021/2282 entered into application, creating a legal basis for Member States' cooperation on joint clinical assessments of medicines and medical devices. 

The key activities HTACG subgroups related to medical devices and in-vitro diagnostics in 2025 included the following:

• The Joint Clinical Assessments (JCA) subgroup is responsible for developing a draft recommendation to HTACG regarding the selection of medical devices and in-vitro diagnostics (IVDs) for JCA. A pilot on the recommendation process was conducted, providing practical experience with the application of the selection criteria, the timeline, and the development of a template recommendation for the selection of medical devices and IVDs. The first JCA for medical devices and IVDs will start in 2026.
• The Joint Scientific Consultations (JSC) subgroup opened two request periods for consultations. However, no requests were received from the developers of medical devices or IVDs in 2025.
• The Emerging Health Technologies (EHT) subgroup conducted horizon scanning and prepared a report on medicines, medical devices, and IVDs that fall within the scope of the HTAR framework and are to be considered for JCA in 2026.
• The subgroup for the development of methodological and procedural guidance released several guidance documents for JCA and JSC of medical devices and IVDs.

See more details here.

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